MOLOXIN 400 mg Tablets

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Moloxin, 400 mg, film-coated tablets
   1. Read the leaflet carefully before taking the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
3. What is Moloxin and what is it used for
4. Important information before taking Moloxin
   1. When not to take Moloxin
   2. Warnings and precautions
   3. Before starting Moloxin, discuss with your doctor or pharmacist.
   4. While taking Moloxin
   5. Children and adolescents
   6. Moloxin and other medicines
   7. Moloxin with food and drink
   8. Pregnancy, breastfeeding, and fertility
   9. Driving and using machines
   10. Moloxin contains sodium
5. How to take Moloxin
   1. What to do if you take more Moloxin than you should
   2. What to do if you miss a dose of Moloxin
   3. What to do if you stop taking Moloxin
6. Possible side effects
   1. Common side effects (may occur in less than 1 in 10 people):
   2. Uncommon side effects (may occur in less than 1 in 100 people):
   3. Rare side effects (may occur in less than 1 in 1,000 people):
   4. Very rare side effects (may occur in less than 1 in 10,000 people):
   5. Frequency not known (frequency cannot be estimated from available data)
   6. Reporting side effects
7. How to store Moloxin
8. Package contents and other information
   1. What Moloxin contains
   2. How the medicine Moloxin looks like and what the packaging contains
   3. Responsible entity
   4. Manufacturer

Leaflet accompanying the packaging: patient information

Moloxin, 400 mg, film-coated tablets

moxifloxacin

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is Moloxin and what is it used for
• 2. Important information before taking Moloxin
• 3. How to take Moloxin
• 4. Possible side effects
• 5. How to store Moloxin
• 6. Package contents and other information

1. What is Moloxin and what is it used for

Moloxin contains the active substance moxifloxacin, which belongs to a group of antibiotics called fluoroquinolones. Moloxin has a bactericidal effect on bacteria that cause infections.
Moloxin is used in patients aged 18 and older to treat the following bacterial infections, if they are caused by bacteria susceptible to moxifloxacin. Moloxin can only be used to treat these infections if the use of commonly administered antibiotics is not possible or if they have been ineffective:
Sinusitis, acute exacerbation of chronic bronchitis or pneumonia, when the infection did not occur in the hospital (except for severe cases).
Mild to moderate upper genital tract infections (pelvic inflammatory disease), including fallopian tube and endometrial infections. Moloxin alone is not sufficient to treat this type of infection, so the doctor should prescribe an additional antibacterial medicine to treat upper genital tract infections (see section 2, "Important information before taking Moloxin", "Warnings and precautions" and "Before starting Moloxin, discuss with your doctor or pharmacist").
If the patient's condition improves as a result of taking moxifloxacin in the form of an infusion solution during the treatment of the following bacterial infections, the doctor may also prescribe Moloxin in the form of film-coated tablets to complete the treatment:
Community-acquired pneumonia, skin and soft tissue infections.
Moloxin should not be used to start treatment for any type of skin and soft tissue infection or in severe pneumonia.

2. Important information before taking Moloxin

If the patient has any doubts about belonging to any of the described groups, they should contact their doctor.

When not to take Moloxin

• If the patient is allergic to moxifloxacin, other quinolone antibiotics, or any of the other ingredients of this medicine (listed in section 6).
• During pregnancy and breastfeeding.
• In patients under 18 years of age.
• If the patient has a history of tendon problems related to treatment with other quinolone antibiotics (see section 2, "Important information before taking Moloxin", "Warnings and precautions" and section 4, "Possible side effects").
• If the patient has congenital or acquired:
• any conditions related to abnormal heart rhythm (visible on an ECG),
• electrolyte imbalance disorders (especially decreased potassium or magnesium levels in the blood),
• very slow heart rate (bradycardia),
• heart failure,
• history of heart rhythm disorders (arrhythmias) or
• if the patient is taking medicines that may cause abnormal changes in the ECG (see section 2, "Important information before taking Moloxin", "Moloxin and other medicines"). Moloxin may cause changes in the ECG, known as QT interval prolongation, which means delayed conduction of electrical signals in the heart.
• If the patient has severe liver disease or liver enzyme activity (transaminases) exceeding 5 times the upper limit of normal.

Warnings and precautions

Before taking this medicine
Do not take antibacterial medicines containing fluoroquinolones or quinolones, including Moloxin, if the patient has experienced any severe side effects while taking a quinolone or fluoroquinolone in the past. In such a situation, the doctor should be informed as soon as possible.

Before starting Moloxin, discuss with your doctor or pharmacist.

• Moloxin may change the heart's ECG, especially in women and the elderly. When taking medicines that lower potassium levels in the blood, consult a doctor before starting Moloxin (see also section 2, "Important information before taking Moloxin", "When not to take Moloxin" and "Moloxin and other medicines").
• If the patient has been diagnosed with a dilated large blood vessel (aortic or large peripheral artery aneurysm).
• If the patient has had a tear in the aorta (aortic dissection) in the past.
• If the patient has been diagnosed with heart valve problems.
• If there have been cases of aortic aneurysm or aortic dissection in the patient's family, or other risk factors or conditions (e.g., connective tissue diseases such as Marfan syndrome, Ehlers-Danlos syndrome, Turner syndrome, or Sjögren's syndrome (an autoimmune inflammatory disease), or vascular diseases such as Takayasu arteritis, giant cell arteritis, Behçet's disease, hypertension, or confirmed atherosclerosis, rheumatoid arthritis (joint disease), or endocarditis).
• In case of epilepsyor conditions that may cause seizures, consult a doctor before starting Moloxin.
• If the patient has or has had mental health problems, consult a doctor before starting Moloxin.
• If the patient suffers from myasthenia gravis(a type of muscle weakness that can lead to paralysis in severe cases), taking Moloxin may worsen the symptoms of the disease. If this happens, consult a doctor immediately.
• In case of glucose-6-phosphate dehydrogenase deficiency(a rare inherited disease), inform the doctor, who will assess whether Moloxin is a suitable medicine.
• If the patient has a complicated upper genital tract infection(e.g., when there is an abscess of the fallopian tube, ovary, or pelvic area), the doctor may consider it necessary to administer moxifloxacin intravenously, as taking Moloxin in the form of tablets is not appropriate.
• To treat mild to moderate upper genital tract infections, the doctor should prescribe an additional antibacterial medicine to the patient, in addition to Moloxin. If the symptoms do not start to improve within the first 3 days of treatment, the patient should consult a doctor. If the patient has diabetes, as moxifloxacin may increase the risk of changes in blood sugar levels.
• If the patient has ever experienced a severe skin rash or peeling of the skin after taking moxifloxacin, with blisters and (or) ulcers of the mouth.

While taking Moloxin

• If heart palpitations or irregular heartbeatoccur during treatment, consult a doctor immediately. The doctor may want to perform an ECG to check the heart rhythm.
• The risk of heart rhythm disordersmay increase with increasing doses. Therefore, the recommended dosage of Moloxin should be followed.
• There is a small risk of a severe, sudden allergic reaction(anaphylactic reaction or anaphylactic shock) even after the first dose of the medicine, with symptoms such as chest tightness, dizziness, weakness or fainting, and dizziness when standing up. If these symptoms occur, stop taking Moloxin and consult a doctor immediately.
• Moloxin may cause liver inflammation with a rapid and severe course, which can lead to life-threatening liver failure (including death, see section 4, "Possible side effects"). Consult a doctor before continuing treatmentif symptoms such as rapid deterioration of well-being and (or) health condition, yellowing of the whites of the eyes, dark urine, itching of the skin, tendency to bleed, and liver-related disorders of brain function (symptoms of impaired liver function or rapidly progressing and severe liver inflammation) occur.
• Antibiotics from the quinolone group, including Moloxin, may cause seizures. If seizures occur, stop taking Moloxin and consult a doctor immediately.
• Long-term, disabling, and potentially irreversible severe side effects.
• Fluoroquinolone and quinolone antibacterial medicines, including Moloxin, have been associated with very rare but severe side effects. Some of them were long-term (lasting for months or years), disabling, or potentially irreversible. These include: tendon, muscle, and joint pain in the upper and lower limbs, difficulty walking, abnormal sensations such as tingling, burning, itching, numbness, or pain (paresthesia), sensory disturbances, including vision, taste, and smell and hearing disorders, depression, memory disorders, severe fatigue, and severe sleep disorders. If any of these side effects occur after taking Moloxin, consult a doctor immediately before continuing treatment. The patient and doctor will decide whether to continue treatment, also considering antibiotics from another group.
• The patient may rarely experience nerve damage symptoms(neuropathy) such as pain, burning, tingling, numbness, and (or) weakness, especially in the feet and legs and hands and arms. In

such a case, stop taking Moloxin and inform the doctor immediately to prevent the development of a potentially irreversible disease.

• Mental health problemsmay occur, even during the first use of quinolone antibiotics, including Moloxin. In very rare cases, depression or mental health problems may lead to suicidal thoughts and self-destructive behaviors, such as suicide attempts (see section 4, "Possible side effects"). If such reactions occur, stop taking Moloxin and consult a doctor immediately.
• During or after the use of antibiotics, including Moloxin, diarrheamay occur. If severe or prolonged diarrhea or blood and (or) mucus in the stool occur, stop taking Moloxin and consult a doctor immediately.In such a situation, do not use medicines that slow down or stop bowel movements (peristalsis).
• Joint and tendon pain and inflammation or tendon rupturemay rarely occur. The risk is increased in elderly people (over 60 years), after organ transplantation, in cases of kidney problems, or during corticosteroid treatment. Tendon inflammation and rupture may occur within the first 48 hours of treatment and even several months after stopping Moloxin. If the first symptoms of pain or tendon inflammation occur (e.g., in the ankle, wrist, elbow, shoulder, or knee), stop taking Moloxin, consult a doctor, and rest the affected area. Avoid excessive exertion, as it may increase the risk of tendon rupture (see section 2, "Important information before taking Moloxin", "When not to take Moloxin" and section 4, "Possible side effects").
• In case of sudden severe abdominal, back, or chest pain, which may be a sign of an aneurysm and aortic dissection, seek emergency medical attention immediately. The risk of these changes may be higher during treatment with systemic corticosteroids.
• In case of sudden shortness of breath, especially when lying down, or swelling of the ankles, feet, or abdomen, or an irregular heartbeat (feeling of rapid or irregular heartbeat), consult a doctor immediately.
• Fluoroquinolone antibiotics may cause an increase in blood sugar levels above normal (hyperglycemia) or a decrease in blood sugar levels below normal (hypoglycemia), which can potentially lead to loss of consciousness (hypoglycemic coma) in severe cases (see section 4, "Possible side effects"). In diabetic patients, blood sugar levels should be closely monitored.
• Elderly patients with kidney function disordersshould drink an adequate amount of fluids, as dehydration may increase the risk of kidney failure.
• If the patient's vision worsens or other vision disordersoccur during Moloxin treatment, consult an ophthalmologist immediately(see section 3, "How to take Moloxin", "Driving and using machines" and section 4, "Possible side effects").
• Fluoroquinolone antibiotics may increase sensitivity of the skin to sunlight or UV radiation. During Moloxin treatment, avoid prolonged sun exposure, strong sunlight, and use of sunbeds or other sources of UV radiation (see section 4, "Possible side effects").
• The efficacy of moxifloxacin has not been established in the treatment of severe burns, deep tissue infections, and diabetic foot infections with bone marrow infection (osteomyelitis).

Severe skin reactions
During moxifloxacin treatment, severe skin reactions have been reported, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS).

• SJS/TEN may initially appear as reddish spots with a target-like appearance or round spots, often with blisters on the torso. They may also cause ulcers in the mouth, throat, nose, genitals, and eyes (red and swollen eyes). The occurrence of such severe skin rashes is often preceded

by fever and (or) flu-like symptoms. Rashes may transform into generalized skin peeling and life-threatening complications or lead to death.

• AGEP appears at the beginning of treatment as a red, peeling, generalized rash with nodules under the skin and blisters, accompanied by fever. The most common location: mainly localized to skin folds, torso, and upper limbs.
• In DRESS, the initial symptoms are flu-like and a rash on the face, followed by a widespread rash with high body temperature, elevated liver enzymes, and an increased number of white blood cells (eosinophilia), as well as swollen lymph nodes. If a severe rash or any of these skin symptoms occur, stop taking moxifloxacin and consult a doctor or seek immediate medical attention.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age, as the efficacy and safety of its use in this age group have not been established (see section 2, "Important information before taking Moloxin", "When not to take Moloxin").

Moloxin and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take.
When taking Moloxin, you should know that:

• In case of taking Moloxin with other medicines affecting heart function, there is an increased risk of heart rhythm disorders. Therefore, do not take Moloxin at the same time as the following medicines:
• medicines belonging to the group of antiarrhythmic medicines (e.g., quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide),
• antipsychotic medicines (e.g., phenothiazines, pimozide, sertindole, haloperidol, sultopride),
• tricyclic antidepressants,
• certain medicines used in infections (e.g., saquinavir, sparfloxacin, intravenous erythromycin, pentamidine, antimalarial medicines, especially halofantrine),
• certain antihistamines (e.g., terfenadine, astemizole, mizolastine),
• other medicines (e.g., cisapride, intravenous vincamine, bepridil, and difemanil).
• Tell your doctor about taking medicines that may decrease potassium levels in the blood (e.g., certain diuretics, certain laxatives, and enemas [in large doses] or glucocorticosteroids [anti-inflammatory medicines], amphotericin B), as this may increase the risk of severe heart rhythm disorders when taking Moloxin.
• Medicines containing magnesium or aluminum(such as antacids used in digestive disorders), medicines containing iron or zinc, medicines containing didanosine, and medicines containing sucralfate(used in the treatment of gastrointestinal disorders) may reduce the effectiveness of Moloxin. Therefore, maintain a 6-hour interval between taking Moloxin and these medicines.
• Concomitant administration of a charcoaland Moloxin may reduce the effectiveness of Moloxin. Therefore, it is not recommended to take both medicines at the same time.
• In case of concomitant use of blood-thinning medicines(oral anticoagulants such as warfarin), the doctor may order blood clotting tests.

Moloxin with food and drink

Moloxin can be taken with or without food (including dairy food).

Pregnancy, breastfeeding, and fertility

Do not take Moloxin during pregnancy and breastfeeding.
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult a doctor or pharmacist before taking this medicine.
Animal studies have not shown an effect on fertility during moxifloxacin treatment.

Driving and using machines

Moloxin may cause dizziness and dizziness, sudden transient loss of vision, or short-term fainting. If such symptoms occur, do not drive vehicles or operate machines.

Moloxin contains sodium

This medicine contains less than 1 mmol (23 mg) of sodium per tablet, which means the medicine is considered "sodium-free".

3. How to take Moloxin

Always take this medicine exactly as your doctor or pharmacist has told you. If you are not sure, consult your doctor or pharmacist.
The usual dose for adults is 1 film-coated tablet of 400 mg once a day.
Moloxin tablets are taken orally. Swallow the tablet whole (to mask the bitter taste) with a large amount of liquid. Moloxin can be taken with or without food (including dairy food).
It is recommended to take the medicine at the same time every day.
No dose adjustment is necessary in elderly patients, patients with low body weight, or patients with kidney function disorders.
The duration of treatment depends on the type of infection. Unless otherwise prescribed by the doctor, the recommended duration of Moloxin treatment is:

• acute exacerbation of chronic bronchitis: 5 to 10 days
• pneumonia (pneumonia), except for hospital-acquired pneumonia: 10 days
• acute bacterial sinusitis: 7 days
• mild to moderate upper genital tract infections (pelvic inflammatory disease), including fallopian tube and endometrial infections: 14 days

If Moloxin is used to complete a cycle of moxifloxacin treatment in the form of an infusion solution, the recommended treatment duration is:

• community-acquired pneumonia:
• 7 - 14 days

In most patients with pneumonia, the switch to oral moxifloxacin treatment occurred within 4 days.

• skin and soft tissue infections
• 7 - 21 days

In most patients with skin and soft tissue infections, the switch to oral moxifloxacin treatment occurred within 6 days.
It is essential to complete the full treatment cycle, even if the patient's condition improves after a few days. If the treatment is stopped too early, the infection may not be completely cured, the disease may recur or worsen, and the bacteria may develop resistance to Moloxin.
Do not exceed the recommended dose or prolong the treatment duration (see section 2, "Important information before taking Moloxin", "Warnings and precautions").

What to do if you take more Moloxin than you should

If you have taken more than one prescribed tablet per day, seek medical attention immediatelyand, if possible, take all remaining tablets, packaging, and this leaflet to show the doctor or pharmacist.

What to do if you miss a dose of Moloxin

If you forget to take a tablet at the usual time, take it as soon as you remember that day.If you miss a dose one day, take the usual dose (one tablet) the next day. Do not take a double dose to make up for the missed dose.
In case of doubts about taking this medicine, consult a doctor or pharmacist.

What to do if you stop taking Moloxin

If you stop taking the medicine too early, the infection may not be completely cured. If you need to stop treatment early, consult a doctor.
In case of further doubts about taking this medicine, consult a doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious side effectsobserved during moxifloxacin treatment are listed below.

• abnormal heart rhythm (rare side effect),
• rapid deterioration of well-being, yellowing of the whites of the eyes, dark urine, itching of the skin, tendency to bleed, and disorders of thinking or insomnia [these may be objective and subjective symptoms of fulminant hepatitis that can lead to life-threatening liver failure, including death (very rare side effect)],
• severe skin rash, including Stevens-Johnson syndrome and toxic epidermal necrolysis. It may appear as reddish spots with a target-like appearance or round spots, often with blisters on the torso, peeling skin, ulcers in the mouth, throat, nose, genitals, and eyes, and may be preceded by fever and flu-like symptoms (very rare side effects, potentially life-threatening),
• red, peeling, generalized rash with nodules under the skin and blisters, which is accompanied by fever at the beginning of treatment (acute generalized exanthematous pustulosis) (frequency of this side effect is "unknown" - frequency cannot be estimated from available data),
• widespread rash, high body temperature, elevated liver enzymes, and blood abnormalities (eosinophilia), as well as swollen lymph nodes (drug reaction with eosinophilia and systemic symptoms, also known as DRESS) (frequency of this side effect is "unknown"),
• syndrome associated with water retention and low sodium levels (SIADH) (very rare side effect),
• loss of consciousness due to significantly decreased blood sugar levels (hypoglycemic coma) (very rare side effect),
• vasculitis (which may be characterized by red spots on the skin, usually on the lower part of the legs or pain in the tendons) (very rare side effect),
• severe, life-threatening allergic reaction, including very rare anaphylactic shock (e.g., difficulty breathing, low blood pressure, rapid heartbeat) (rare side effect),
• swelling, including swelling of the airways (rare side effect, potentially life-threatening),
• seizures (rare side effect),
• nerve-related problems, such as pain, burning, tingling, numbness, and (or) weakness (rare side effect),
• depression (very rarely leading to self-harm, e.g., suicidal thoughts or attempts) (rare side effect),
• psychiatric disorders (which may lead to self-harm, e.g., suicidal thoughts or attempts) (very rare side effect),
• severe diarrhea with blood and (or) mucus in the stool (antibiotic-associated colitis, including pseudomembranous colitis), which can very rarely be associated with life-threatening complications (rare side effects),
• tendon pain and swelling (tendinitis) (rare side effect) or tendon rupture (very rare side effect),
• weakness, tenderness, or muscle pain, especially if accompanied by malaise, high fever, or dark urine. This may be due to abnormal muscle tissue breakdown, which can be life-threatening and lead to kidney problems (a condition known as rhabdomyolysis) (frequency of this side effect is "unknown"), stop taking Moloxin and consult a doctor immediately, as immediate medical attention may be necessary.

In addition, if:

• transient loss of vision (very rare side effect),
• discomfort or eye pain, especially when exposed to light (very rare side effect), consult an ophthalmologist immediately.

If the patient experiences a life-threatening irregular heartbeat (torsades de pointes) or cardiac arrest while taking Moloxin (very rare side effect), inform the attending doctor that the patient is taking Moloxin and do not resume treatment.
Very rarely, worsening of myasthenia gravis symptoms has been observed. If the patient's myasthenia gravis symptoms worsen, consult a doctor immediately.
If the patient with diabetes experiences an increase or decrease in blood sugar levels (rare or very rare side effect), inform the doctor immediately.
If the elderly patient with kidney function disorders experiences a decrease in urine output, swelling of the feet, ankles, or hands, fatigue, nausea, drowsiness, shortness of breath, or confusion (which may be objective and subjective symptoms of kidney failure; rare side effect), consult a doctor immediately.
Other side effectsobserved during moxifloxacin treatment are listed below, according to their frequency:

Common side effects (may occur in less than 1 in 10 people):

• nausea
• diarrhea
• central dizziness
• abdominal pain
• vomiting
• headache
• increased activity of certain liver enzymes (transaminases) in the blood
• infections caused by resistant bacteria or fungi, e.g., thrush in the mouth and vagina caused by Candida(candidiasis)
• heart rhythm disorders (visible on an ECG) in patients with low potassium levels in the blood

Uncommon side effects (may occur in less than 1 in 100 people):

• rash
• gastrointestinal disorders (dyspepsia and heartburn)
• taste disorders (in very rare cases, loss of taste)
• sleep disorders (mainly insomnia)
• increased activity of certain liver enzymes: gamma-glutamyltransferase and (or) alkaline phosphatase
• low count of certain white blood cells (leukocytes, neutrophils)
• constipation
• itching
• vertigo (feeling of spinning or rotating)
• drowsiness
• wind
• heart rhythm disorders (visible on an ECG)
• liver function disorders, including increased activity of the liver enzyme LDH in the blood
• decreased appetite and food intake
• low white blood cell count
• mild discomfort, such as back pain, chest pain, pelvic pain, or limb pain
• increased platelet count necessary for blood clotting
• excessive sweating
• increased count of certain white blood cells (eosinophils)
• anxiety
• malaise (mainly weakness or fatigue)
• tremor
• joint pain
• palpitations
• irregular and rapid heartbeat
• breathing difficulties, including asthma symptoms
• increased activity of the digestive enzyme amylase in the blood
• anxiety, especially motor anxiety, or agitation
• tingling or (and) numbness
• hives
• vasodilation
• confusion and disorientation
• decreased platelet count necessary for blood clotting
• vision disorders, including double or blurred vision
• decreased blood clotting
• increased levels of fats in the blood
• low red blood cell count (anemia)
• muscle pain
• allergic reaction
• increased bilirubin levels in the blood
• gastritis
• dehydration
• severe heart rhythm disorders
• dry skin
• angina pectoris

Rare side effects (may occur in less than 1 in 1,000 people):

• muscle tremors
• muscle cramps
• hallucinations
• high blood pressure
• swelling (hands, feet, ankles, lips, mouth, or throat)
• low blood pressure
• kidney function disorders, including increased values of diagnostic tests for kidney function, such as urea and creatinine levels
• hepatitis
• stomatitis
• ringing or noise in the ears (tinnitus)
• jaundice (yellowing of the whites of the eyes and skin)
• skin sensation disorders
• unusual dreams
• concentration disorders
• swallowing difficulties
• smell disorders, including loss of smell
• balance and coordination disorders (due to dizziness)
• partial or complete memory loss
• hearing disorders, including deafness (usually transient)
• increased uric acid levels in the blood
• emotional instability
• speech disorders
• fainting
• muscle weakness

Very rare side effects (may occur in less than 1 in 10,000 people):

• arthritis
• heart rhythm disorders
• increased skin sensitivity
• depersonalization (feeling of loss of one's identity)
• increased blood clotting
• muscle stiffness
• significant decrease in a specific type of white blood cells (agranulocytosis)
• decrease in the number of red and white blood cells and platelets (pancytopenia)

Frequency not known (frequency cannot be estimated from available data)

• Increased sensitivity of the skin to sunlight or UV radiation (see also section 2, "Warnings and precautions").
• Sharply limited, reddish spots with blisters or without blisters, which appear within a few hours of moxifloxacin administration and heal with post-inflammatory pigmentation; usually recur in the same area of skin or mucous membrane after re-exposure to moxifloxacin

Administration of quinolone and fluoroquinolone antibiotics, in some cases regardless of existing risk factors, has very rarely caused long-term (lasting for months or years) or permanent drug side effects, such as tendonitis, tendon rupture, joint and limb pain, difficulty walking, abnormal sensations such as tingling, burning, itching, numbness, or pain (neuropathy), fatigue, memory and concentration disorders, and hearing, vision, taste, and smell disorders.
Patients treated with fluoroquinolones have reported cases of aortic dilatation and aortic aneurysm or aortic dissection, which can be fatal, as well as cases of heart valve problems. See also section 2.
Additionally, the following side effects have been very rarely reported during treatment with other quinolone antibiotics, which may also occur during Moloxin treatment:

• increased intracranial pressure (symptoms include headache, vision problems, including blurred vision, "blind" spots, double vision, loss of vision)
• increased sodium levels in the blood
• increased calcium levels in the blood
• a specific type of decreased red blood cell count (hemolytic anemia)

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Moloxin

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month.
The batch number is stated on the packaging after "Lot".
Store in the original packaging to protect from moisture.
No special precautions for storage temperature are necessary.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Package contents and other information

What Moloxin contains

• The active substance of Moloxin is moxifloxacin. Each film-coated tablet contains moxifloxacin hydrochloride equivalent to 400 mg of moxifloxacin.
• The other ingredients are: microcrystalline cellulose, sodium croscarmellose, magnesium stearate in the tablet core, and hypromellose 6 mPa·s, macrogol 4000, titanium dioxide (E171), and red iron oxide (E172) in the tablet coating. See section 2, "Moloxin contains sodium".

How the medicine Moloxin looks like and what the packaging contains

Dark pink, biconvex, film-coated tablets in the shape of a capsule, with dimensions: length 15.9 mm

• 16.6 mm and thickness 5.8 mm - 7.0 mm.

Packaging: 5, 7, 10, 14, 25, 28, 30, 50, 70, 80, 100 or 120 film-coated tablets in blisters
in a cardboard box.
Not all pack sizes may be marketed.

Responsible entity

KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d. d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
KRKA-FARMA d.o.o., V. Holjevca 20/E, 10 450 Jastrebarsko, Croatia
This medicinal product is authorized in the Member States of the European Economic Area under the following names:
In order to obtain more detailed information, please contact the representative of the responsible entity:
KRKA-POLSKA Sp. z o.o.
ul. Równoległa 5
02-235 Warsaw
Tel. 22 57 37 500
Date of last update of the leaflet:06.02.2025